FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE MRI DR
MDR report key: 21236894
·
Received January 25, 2025
Report
- Report Number
- 2124215-2025-03626
- Event Type
- Malfunction
- Date Received
- January 25, 2025
- Date of Event
- December 27, 2024
- Report Date
- January 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526559228
- PMA / PMN Number
- P150012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED FARFIELD OVERSENSING ON THE ATRIAL CHANNEL POST VENTRICULAR PACE. TECHNICAL SERVICES SUGGESTED REPROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1606675 | ACCOLADE MRI DR | IMPLANTABLE PACEMAKER | LWP | BOSTON SCIENTIFIC CORPORATION | L311 | 837133 | 00802526559228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |